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- ICH Official web site : ICH
Founded 35 years ago and registered as a non-profit legal entity under Swiss law in 2015, ICH has finalised nearly 80 Guidelines that are applied by regulatory authorities around the world ICH has 25 members, 41 observers, and a network of close to 700 experts globally
- ICH Official web site : ICH
It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI)
- ICH Official web site : ICH
The ICH Harmonised Guideline was finalised under Step 4 in February 2002 This document is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability Guideline
- VALIDATION OF ANALYTICAL PROCEDURES Q2(R2)
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process
- ICH Official web site : ICH
The ICH Harmonised Guideline was finalised under Step 4 in November 2011 It replaces and combines the ICH S2A and S2B Guidelines The S2A Guideline on Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals was finalised under Step 4 in July 1995
- Q1A(R2) - ICH
It is recommended that registration applications contain data from complete studies at the intermediate storage condition 30°C ± 2°C 65% RH ± 5% RH, if applicable, by three years after the date of publication of this revised guideline in the respective ICH tripartite region
- IMPURITIES GUIDELINE FOR RESIDUAL S Q3C(R8) - ICH
Having reached Step 4 of the ICH Process and incorporated into the core Guideline on 9 November 2016 this Guideline is recommended for adoption to the regulatory parties to ICH
- Annex 10 - ICH
The guidelines cross-refer to the series of related documents published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (2) and other WHO guidelines
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